DiabetesPhase 1NCT06547502
Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment
A Phase 1 study testing GZR4 in people with Diabetes, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- GZR4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2024to 5 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
- Meeting the pre-defined Glomerular Filtration Rate (GFR) values
Who cannot join
- Known or suspected hypersensitivity to trial product
- Drugs known to affect creatinine clearance including cimetidine within 14 days or 5 half-lives prior to the day of dosing of GZR4 and during this trial
- Individuals who routinely undergo dialysis or have a history of renal transplantation, hepatorenal syndrome, or acute kidney injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of Pharmacokinetics and Safety of a Single Dose of GZR4 Injection in Subjects with Mild to Moderate Renal Impairment and Subjects with Normal Renal Function
This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.
- Conditions
- Diabetes
- Being tested
- GZR4
- Keywords
- GZR4, kidney
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR4Drug
single dose
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Experimental | GFR between 90-130 ml/min Receives: Drug: GZR4 |
| Mildly decreased renal function | Experimental | GFR between 60-90 ml/min Receives: Drug: GZR4 |
| moderately decreased renal function | Experimental | GFR between 30-60 ml/min Receives: Drug: GZR4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Measured: Day1-Day29
AUC0-last
Measured: Day1-Day29
Cmax
Measured: Day1-Day29
Secondary outcomes (4)
Incidence of TEAE
Measured: Day1-Day29
AUC0-168h
Measured: Day1-Day29
Tmax
Measured: Day1-Day29
T1/2
Measured: Day1-Day29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start3 Jul 2024
- Primary completion20 Aug 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547502
- Sponsor's protocol ID
- GZR4-T2D-104
- Status last verified
- Dec 2024
- First submitted
- 7 Aug 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Pharmacokinetics and Safety of a Single Dose of GZR4 Injection in Subjects with Mild to Moderate Renal Impairment and Subjects with Normal Renal Function
- ClinicalTrials.gov ID
- NCT06547502
- Acronym / sponsor ID
- GZR4-T2D-104
- Conditions
- Diabetes
- Keywords
- GZR4, kidney
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Experimental | Drug: GZR4GFR between 90-130 ml/min |
| Mildly decreased renal function | Experimental | Drug: GZR4GFR between 60-90 ml/min |
| moderately decreased renal function | Experimental | Drug: GZR4GFR between 30-60 ml/min |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
- Meeting the pre-defined Glomerular Filtration Rate (GFR) values
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to trial product
- Drugs known to affect creatinine clearance including cimetidine within 14 days or 5 half-lives prior to the day of dosing of GZR4 and during this trial
- Individuals who routinely undergo dialysis or have a history of renal transplantation, hepatorenal syndrome, or acute kidney injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GZR4single dose | Drug | Mildly decreased renal function, Normal renal function, moderately decreased renal function |
Primary outcome
AUC0-inf
Time frame: Day1-Day29
AUC0-last
Time frame: Day1-Day29
Cmax
Time frame: Day1-Day29
4 secondary outcomes
Incidence of TEAE
Time frame: Day1-Day29
AUC0-168h
Time frame: Day1-Day29
Tmax
Time frame: Day1-Day29
T1/2
Time frame: Day1-Day29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZR4 in people with Diabetes, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf (time frame: Day1-Day29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.